Long COVID FatigueNCT07745699
Fully Remote, Telehealth-based Ketogenic Metabolic Therapy for Long COVID
A study testing Ketogenic Metabolic Therapy and Lifestyle Intervention in people with Long COVID Fatigue, run by National University of Natural Medicine at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if a 12-week ketogenic diet program combined with lifestyle strategies (called KMT-LS) is practical and acceptable as a fully remote intervention for adults with Long COVID who also have Myalgic Encephalomyelitis/Chronic Fatigue Syndrome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Long COVID Fatigue
- What is being tested?
- Ketogenic Metabolic Therapy and Lifestyle Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Dec 2024to 1 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- English-speaking
- Suspected, probable, or confirmed SARS-CoV-2 infection as defined by the Pan American Health Organization
- Long COVID diagnosed via structured clinical interview, consistent with the World Health Organization clinical case definition and the National Academies of Sciences, Engineering, and Medicine (2024) definition
- Physician-confirmed diagnosis of post-infectious dysautonomia and ME/CFS; OR self-reported dysautonomia symptoms with a Malmö POTS Score Assessment (MAPS) score greater than 40
- Met the National Academy of Medicine diagnostic criteria for ME/CFS
Who cannot join
- Known pregnancy or planning pregnancy during the study period
- Active cancer diagnosis
- Renal or liver failure
- Pancreatitis
- Atrial fibrillation or significant cardiac arrhythmia
- Significant atherosclerotic disease
Show all 14Show fewer
- Uncontrolled hypertension or hypertriglyceridemia
- Active or recent thrombosis
- Use of antiepileptic medications
- Use of SGLT-2 inhibitors
- Substance use disorder
- Type I diabetes
- History of inborn errors of metabolism
- Previous completion of a nutritional and lifestyle program for this condition
Trial locations and contacts
1 site in 1 country.
United States1 site
National University of Natural Medicine
Portland, Oregon, 97229
About this study
Official title: A National, Fully Decentralized, Telehealth-Based Ketogenic Metabolic Therapy Intervention for Individuals With Long COVID: A 12-Week, Single-Arm Feasibility and Acceptability Trial Targeting ME/CFS and POTS Phenotypes
The goal of this clinical trial is to learn if a 12-week ketogenic diet program combined with lifestyle strategies (called KMT-LS) is practical and acceptable as a fully remote intervention for adults with Long COVID who also have Myalgic Encephalomyelitis/Chronic Fatigue Syndrome. (ME/CFS) and dysautonomia (problems with heart rate, blood pressure, or other automatic body functions).
The main questions it aims to answer are:
Read more
Can a ketogenic diet program be successfully delivered entirely from home using online tools and virtual support?
Do participants stay in the study, follow the diet, and find the program safe and satisfactory?
Do participants experience improvements in fatigue, sleep, mood, daily functioning, and symptom flare-ups after exertion?
Participants will:
Follow a ketogenic diet for 12 weeks with weekly virtual nutrition support sessions
Use at-home tools to track their ketone levels and confirm they are following the diet
Complete online questionnaires about their symptoms, energy, sleep, mood, and daily functioning at the start of the study, after 12 weeks, and again 3 months later.
- Conditions
- Long COVID Fatigue
- Being tested
- Ketogenic Metabolic Therapy, Lifestyle Intervention
- Keywords
- Long COVID, Post COVID, post-viral dysautonomia, ketogenic metabolic therapy, infection-associated chronic illness, patient-perspectives, whole-person health design
- Medical subject headings
- Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketogenic Metabolic TherapyOther
Keto-Life is a fully remote, community-based program for individuals with Long COVID, dysautonomia, and ME/CFS that combines a ketogenic diet with lifestyle strategies.
Participants followed a ketogenic diet (low-carbohydrate, moderate-protein, high-fat) with a personalized intermittent eating schedule, no added sugar, and daily benfotiamine (vitamin B1) supplementation. Electrolyte support included magnesium, potassium, sodium bicarbonate, and sodium chloride. Nutrition calls were once a week via Telehealth platform, delivered by a medical nutritionist.
Lifestyle InterventionBehavioural
Lifestyle strategies included circadian entrainment, mindfulness practices, and, when appropriate, gentle exercise and hormetic therapies such as cold or heat exposure.
The Lifestyle Intervention was delivered via two 60-minute virtual group sessions, delivered by health coaches.
| Study group | Role | What they receive |
|---|---|---|
| ketogenic metabolic therapy with lifestyle strategies (KMT-LS) | Experimental | Not described Receives: Other: Ketogenic Metabolic Therapy; Behavioral: Lifestyle Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability
Acceptability data were measured via participants' perception of treatment suitability using a 5-point Likert scale (e.g., 1 = Not at all helpful; 5 = Extremely helpful). Participants were asked to rate their level of satisfaction with the program, the perceived helpfulness and relevance of the program, and the likelihood of recommending the program to others. Assessment burden was measured using a 5-point Likert scale (1 = Strongly Disagree, 2 = Disagree, 3 = Undecided, 4 = Agree, 5 = Strongly Agree). Participants were asked to rate the burden associated with sourcing food, cooking food, and completing assessment procedures. Further, acceptability was explored via questions pertaining to optimization of the study, including opinions on dosing and duration of the intervention.
Measured: Acceptability data was collected at post-intervention (Week 13).
Feasibility
Feasibility of the research procedures and remote intervention was evaluated using metrics of enrollment (target sample size n = 10), attrition, population characteristics (e.g., percentage of participants identifying as non-white), completion of data-collection procedures within a 2-week window, amount of missing data, dietary adherence, and safety. The target sample size of 10 was selected to optimize group dynamics for the interactive, group-based components of the ketogenic metabolic therapy intervention, including weekly nutrition calls. Attendance at the weekly nutrition calls was recorded. We assessed adherence to dietary recommendations through participant self-report and objective metabolic data. Participants measured fasting capillary blood β-hydroxybutyrate (BHB) and fasting blood glucose using a commercially available, FDA-registered at-home device (Keto Mojo Meter, Keto Mojo, Inc.).
Measured: Acceptability data was collected during at baseline, Weeks 1-12, and post-intervention (Week 13).
Secondary outcomes (6)
PROMIS-29
PROMIS-29 to assess self-reported levels of physical, social, and cognitive functioning, anxiety, depression, pain interference, and sleep disturbance. Each subscale is standardized to a T-score (Mean = 50, SD = 10), where higher scores represent more of the concept being measured (e.g., more anxiety or better physical function). A threshold of 3 T-score points is considered a minimal clinically important difference (MCID) for each subscale
Measured: Baseline, Post-intervention (13 Week), and 3-month follow-up
Duke Activity Status Index
Measured functional capacity using a 12-item self-report questionnaire that assesses the ability to perform specific activities of daily living. Each item is weighted by its metabolic equivalent value, with total scores ranging from 0 to 58.2. Higher scores indicate greater functional capacity and serve as a validated surrogate marker for peak oxygen uptake .
Measured: Baseline, Post-Intervention (13-Weeks), 3-Month Follow-up
Modified Medical Research Council Dyspnea Scale
Measures respiratory limitation, which categorizes breathlessness on a 5-point scale (Grade 0-4) based on the level of physical exertion required to elicit shortness of breath. A 1-point increase represents a significant decline in function and is recognized as the MCID.
Measured: Baseline, Post-Intervention (13-Weeks), 3-Month Follow-up
Malmö POTS Symptom Score
MAPS is a self-rated, 12-item visual analogue instrument (0-10 per symptom, total 0-120) that measures orthostatic and autonomic burden. Each item scores current symptom burden; higher totals indicate greater symptom severity.
Measured: Baseline, Post-intervention (13 Weeks), and 3-month follow-up
Good Day/Bad Day Questionnaire
The Bateman Horne Center Good Day/Bad Day Questionnaire is not scored as a symptom-severity index; its two anchors are Hours of Upright Activity (HUA) and the number/proportion of good days, both of which are functional-capacity metrics. More upright hours and a higher good:bad day ratio indicate greater functional capacity and less PEM burden; lower values indicate more severe illness.
Measured: Baseline, Post-Intervention (13-Weeks), 3-Month Follow-up
Satisfaction with Life Scale
Evaluates global life satisfaction using a 5-item instrument that uses a 7-point Likert scale to assess an individual's conscious evaluative judgment of their life. Scores range from 5 (Extremely dissatisfied) to 35 (Extremely satisfied).
Measured: Baseline, Post-intervention (13-Weeks), and 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study start10 Dec 2024
- Primary completion1 Jun 2025
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long COVID FatigueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A national, fully decentralized, single-arm, 12-week proof-of-concept study.
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Natural Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dharma Colgan, National University of Natural Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07745699
- Sponsor's protocol ID
- Keto-Life For Long COVID
- Status last verified
- Nov 2024
- First submitted
- 29 Jul 2026
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified clinical data
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A National, Fully Decentralized, Telehealth-Based Ketogenic Metabolic Therapy Intervention for Individuals With Long COVID: A 12-Week, Single-Arm Feasibility and Acceptability Trial Targeting ME/CFS and POTS Phenotypes
- ClinicalTrials.gov ID
- NCT07745699
- Acronym / sponsor ID
- Keto-Life For Long COVID
- Conditions
- Long COVID Fatigue
- Keywords
- Long COVID, Post COVID, post-viral dysautonomia, ketogenic metabolic therapy, infection-associated chronic illness, patient-perspectives, whole-person health design
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- National University of Natural MedicineUniversity, hospital or other
- Study start
- 10 Dec 2024 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 4 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn if a 12-week ketogenic diet program combined with lifestyle strategies (called KMT-LS) is practical and acceptable as a fully remote intervention for adults with Long COVID who also have Myalgic Encephalomyelitis/Chronic Fatigue Syndrome. (ME/CFS) and dysautonomia (problems with heart rate, blood pressure, or other automatic body functions).
The main questions it aims to answer are:
Can a ketogenic diet program be successfully delivered entirely from home using online tools and virtual support?
Do participants stay in the study, follow the diet, and find the program safe and satisfactory?
Do participants experience improvements in fatigue, sleep, mood, daily functioning, and symptom flare-ups after exertion?
Participants will:
Follow a ketogenic diet for 12 weeks with weekly virtual nutrition support sessions
Use at-home tools to track their ketone levels and confirm they are following the diet
Complete online questionnaires about their symptoms, energy, sleep, mood, and daily functioning at the start of the study, after 12 weeks, and again 3 months later.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A national, fully decentralized, single-arm, 12-week proof-of-concept study.
| Arm | Type | Receives |
|---|---|---|
| ketogenic metabolic therapy with lifestyle strategies (KMT-LS) | Experimental | Other: Ketogenic Metabolic Therapy, Behavioral: Lifestyle Intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 years or older
- English-speaking
- Suspected, probable, or confirmed SARS-CoV-2 infection as defined by the Pan American Health Organization
- Long COVID diagnosed via structured clinical interview, consistent with the World Health Organization clinical case definition and the National Academies of Sciences, Engineering, and Medicine (2024) definition
- Physician-confirmed diagnosis of post-infectious dysautonomia and ME/CFS; OR self-reported dysautonomia symptoms with a Malmö POTS Score Assessment (MAPS) score greater than 40
Key exclusion criteria (14 listed)
- Known pregnancy or planning pregnancy during the study period
- Active cancer diagnosis
- Renal or liver failure
- Pancreatitis
- Atrial fibrillation or significant cardiac arrhythmia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketogenic Metabolic TherapyKeto-Life is a fully remote, community-based program for individuals with Long COVID, dysautonomia, and ME/CFS that combines a ketogenic diet with lifestyle strategies. Participants followed a ketogenic diet (low-carbohydrate, moderate-protein, high-fat) with a personalized intermittent eating schedule, no added sugar, and daily benfotiamine (vitamin B1) supplementation. Electrolyte support included magnesium, potassium, sodium bicarbonate, and sodium chloride. Nutrition calls were once a week via Telehealth platform, delivered by a medical nutritionist. | Other | ketogenic metabolic therapy with lifestyle strategies (KMT-LS) |
| Lifestyle InterventionLifestyle strategies included circadian entrainment, mindfulness practices, and, when appropriate, gentle exercise and hormetic therapies such as cold or heat exposure. The Lifestyle Intervention was delivered via two 60-minute virtual group sessions, delivered by health coaches. | Behavioural | ketogenic metabolic therapy with lifestyle strategies (KMT-LS) |
Primary outcome
Acceptability
Time frame: Acceptability data was collected at post-intervention (Week 13).
Acceptability data were measured via participants' perception of treatment suitability using a 5-point Likert scale (e.g., 1 = Not at all helpful; 5 = Extremely helpful). Participants were asked to rate their level of satisfaction with the program, the perceived helpfulness and relevance of the program, and the likelihood of recommending the program to others. Assessment burden was measured using a 5-point Likert scale (1 = Strongly Disagree, 2 = Disagree, 3 = Undecided, 4 = Agree, 5 = Strongly Agree). Participants were asked to rate the burden associated with sourcing food, cooking food, and completing assessment procedures. Further, acceptability was explored via questions pertaining to optimization of the study, including opinions on dosing and duration of the intervention.
Feasibility
Time frame: Acceptability data was collected during at baseline, Weeks 1-12, and post-intervention (Week 13).
Feasibility of the research procedures and remote intervention was evaluated using metrics of enrollment (target sample size n = 10), attrition, population characteristics (e.g., percentage of participants identifying as non-white), completion of data-collection procedures within a 2-week window, amount of missing data, dietary adherence, and safety. The target sample size of 10 was selected to optimize group dynamics for the interactive, group-based components of the ketogenic metabolic therapy intervention, including weekly nutrition calls. Attendance at the weekly nutrition calls was recorded. We assessed adherence to dietary recommendations through participant self-report and objective metabolic data. Participants measured fasting capillary blood β-hydroxybutyrate (BHB) and fasting blood glucose using a commercially available, FDA-registered at-home device (Keto Mojo Meter, Keto Mojo, Inc.).
6 secondary outcomes
PROMIS-29
Time frame: Baseline, Post-intervention (13 Week), and 3-month follow-up
Duke Activity Status Index
Time frame: Baseline, Post-Intervention (13-Weeks), 3-Month Follow-up
Modified Medical Research Council Dyspnea Scale
Time frame: Baseline, Post-Intervention (13-Weeks), 3-Month Follow-up
Malmö POTS Symptom Score
Time frame: Baseline, Post-intervention (13 Weeks), and 3-month follow-up
Good Day/Bad Day Questionnaire
Time frame: Baseline, Post-Intervention (13-Weeks), 3-Month Follow-up
Satisfaction with Life Scale
Time frame: Baseline, Post-intervention (13-Weeks), and 3-month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Individual participant dataSharing planned: Yes. Deidentified clinical data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketogenic Metabolic Therapy and Lifestyle Intervention in people with Long COVID Fatigue, run by National University of Natural Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability (time frame: Acceptability data was collected at post-intervention (Week 13).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.